U.S. patent application number 11/431416 was filed with the patent office on 2006-11-30 for apparatus and methods for magnetic alteration of anatomical features.
Invention is credited to Richard J. Fecther, Michael R. Harrison, Arthur Moran.
Application Number | 20060271107 11/431416 |
Document ID | / |
Family ID | 38750464 |
Filed Date | 2006-11-30 |
United States Patent
Application |
20060271107 |
Kind Code |
A1 |
Harrison; Michael R. ; et
al. |
November 30, 2006 |
Apparatus and methods for magnetic alteration of anatomical
features
Abstract
Systems and methods for auto-anastomosing a region occupying one
or more hollow viscera of the body are disclosed. The system
includes a first magnetic member configured to be delivered to a
location in the body adjacent the region. A second magnetic member
is configured to be located adjacent the region opposite from the
first magnetic member such that said region is disposed in between
the first magnetic member and the second magnetic member. The first
and second magnetic members are configured to generate an
attractive force to compress tissue in the region between them so
that the tissue in the region necroses as a result of the
compressive force such that tissue surrounding the necrosed tissue
heals together to form an anastomosis. The anstomosis may connect a
fistula between two internal viscera or viscera segments, or create
a stoma from a viscera to an external surface of the body.
Inventors: |
Harrison; Michael R.; (San
Francisco, CA) ; Fecther; Richard J.; (San Rafael,
CA) ; Moran; Arthur; (San Bruno, CA) |
Correspondence
Address: |
JOHN P. O'BANION;O'BANION & RITCHEY LLP
400 CAPITOL MALL SUITE 1550
SACRAMENTO
CA
95814
US
|
Family ID: |
38750464 |
Appl. No.: |
11/431416 |
Filed: |
May 9, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10954995 |
Sep 29, 2004 |
|
|
|
11431416 |
May 9, 2006 |
|
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|
Current U.S.
Class: |
606/237 ; 600/29;
606/60 |
Current CPC
Class: |
A61B 2017/00535
20130101; A61B 2017/00876 20130101; A61B 17/11 20130101; A61B
17/0483 20130101; A61B 17/7055 20130101; A61B 2017/1139 20130101;
A61B 17/1757 20130101; A61B 2090/065 20160201; A61B 17/1114
20130101; A61B 2017/00411 20130101; A61B 17/8076 20130101; A61B
17/70 20130101; A61B 17/1789 20161101; A61B 2017/1103 20130101;
A61B 17/66 20130101 |
Class at
Publication: |
606/237 ;
606/060; 600/029 |
International
Class: |
A61F 5/00 20060101
A61F005/00; A61B 17/56 20060101 A61B017/56; A61F 2/30 20060101
A61F002/30; A61B 17/58 20060101 A61B017/58 |
Claims
1. A method for auto-anastomosing a region of the body, comprising:
delivering a first magnetic member to a first location in the body
adjacent said region; locating a second magnetic member adjacent
said region opposite from said first magnetic member such that said
region is disposed in between said first magnetic member and said
second magnetic member; generating an attractive force between said
first magnetic member and said second magnetic member to compress
tissue in said region between the first magnetic member and said
second magnetic member; and necrosing said tissue in said region as
a result of said compressive force; wherein tissue surrounding said
necrosed tissue heals together to form an anastomosis.
2. A method as recited in claim 1, further comprising: removing
said necrosed tissue and said first and second magnetic members
from said region.
3. A method as recited in claim 2, wherein said necrosed tissue and
said first and second magnetic members are removed from said region
via flow of natural bodily functions.
4. A method as recited in claim 2, said first and second magnetic
members are retrieved from a location at or near said region.
5. A method as recited in claim 1: wherein said region comprises
tissue occupied by first and second internal viscera segments in
the body; wherein said first magnetic member is delivered into said
first viscera segment, and wherein said second magnetic member is
delivered to said second viscera segment at a location in proximity
to said first magnet to generate a compressive force on the tissue
in between first and second viscera segments.
6. A method as recited in claim 5, wherein the anastomosed region
creates a fistula between the first and second viscera
segments.
7. A method as recited in claim 6, wherein the first viscera
segment is located a first viscera, and the second viscera segment
is located in a second viscera in proximity to said first
viscera.
8. A method as recited in claim 6, wherein the first viscera
segment and the second viscera segment are separate sections of the
same viscera.
9. A method as recited in claim 2: wherein said region comprises
tissue occupied by a visceral wall and surrounding tissue between
said visceral wall and an external surface on the body; wherein
said first magnetic member is delivered to said visceral wall,
wherein said second magnetic member is located adjacent said
external surface in proximity to said first magnetic member, and
wherein said anastomosed region creates a stoma between said
visceral wall and said external surface.
10. A method as recited in claim 1, wherein said region comprises
tissue of an organ in the gastrointestinal or urinary tract.
11. A method as recited in claim 1, wherein said first magnetic
member is delivered to said region via a catheter.
12. A system for auto-anastomosing a region of the body,
comprising: a first magnetic member configured to be delivered to a
location in the body adjacent said region; a second magnetic member
configured to be located adjacent said region opposite from said
first magnetic member such that said region is disposed in between
said first magnetic member and said second magnetic member; wherein
said first and second magnetic members are configured to generate
an attractive force to compress tissue in said region between them;
and wherein said tissue in said region necroses as a result of said
compressive force such that tissue surrounding said necrosed tissue
heals together to form an anastomosis.
13. A system as recited in claim 12, wherein said first and second
magnetic members are configured to fall away or be retrieved from
said region.
14. A system as recited in claim 12: wherein said region comprises
tissue occupied by first and second viscera segments in the body;
wherein said first magnetic member is configured to be delivered
into said first viscera segment; and wherein said second magnetic
member is configured to be delivered to said second viscera segment
at a location in proximity to said first magnet to generate a
compressive force on the tissue in the tissue in between first and
second viscera segments.
15. A system as recited in claim 13: wherein said region comprises
tissue occupied by a visceral wall and surrounding tissue between
said visceral wall and an external surface on the body; wherein
said first magnetic member is configured to be delivered to said
visceral wall; wherein said second magnetic member is configured to
be located adjacent said external surface in proximity to said
first magnetic member; wherein said anastomosed region creates a
stoma between said visceral wall and said external surface.
16. A system as recited in claim 12, further comprising: a catheter
configured to deliver said first magnetic member to said location
adjacent said region and release said first magnetic member at said
location.
17. A system as recited in claim 12, wherein first magnetic member
is configured to be delivered to an organ in the gastrointestinal
or urinary tract.
18. A system as recited in claim 12, wherein said first magnetic
member comprises a biocompatible casing.
20. An apparatus for auto-anastomosing a region of the body, said
region comprising a first visceral wall, comprising: a first
magnetic member configured to be delivered to a first location at
the first visceral wall, said first location being adjacent said
region; a second magnetic member configured to be positioned at a
second location adjacent said region opposite from said first
magnetic member such that said region is disposed in between said
first magnetic member and said second magnetic member; wherein said
first and second magnetic members are configured to generate an
attractive force to compress tissue in said region between them;
and wherein said tissue in said region necroses as a result of said
compressive force such that tissue surrounding said necrosed tissue
heals together to form a fistula from said first location to said
second location.
21. An apparatus as recited in claim 20, wherein said first and
second magnetic members are configured to fall away or be retrieved
from said fistula.
22. An apparatus as recited in claim 20: wherein said region
further comprises tissue occupied by a second visceral wall in the
body; wherein said second magnetic member is configured to be
delivered to said second visceral wall at a said second location to
generate a compressive force on the tissue in the tissue in between
first and second visceral walls.
23. An apparatus as recited in claim 21: wherein said region
further comprises abdominal tissue in between said visceral wall
and an external surface on the body; wherein said second magnetic
member is configured to be positioned adjacent said external
surface at said second location; wherein said fistula creates a
stoma connecting said visceral wall to said external surface.
24. An apparatus as recited in claim 23, further comprising: an
intermediate magnetic member configured to be positioned in the
abdominal tissue between the first magnetic member and the second
magnetic member; the intermediate magnet configured to generate a
compressive force between it and both the first magnetic member and
the second magnetic member.
25. An apparatus as recited in claim 24, further comprising: a
catheter configured to deliver said first magnetic member to said
location adjacent said region; wherein said catheter is further
configured to release said first magnetic member at said
location.
26. An apparatus as recited in claim 25, wherein first magnetic
member is configured to be delivered to an organ in the
gastrointestinal or urinary tract.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of copending
application Ser. No. 10/954,995 filed on Sep. 29, 2004,
incorporated herein by reference in its entirety.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not Applicable
INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT
DISC
[0003] Not Applicable
NOTICE OF MATERIAL SUBJECT TO COPYRIGHT PROTECTION
[0004] A portion of the material in this patent document is subject
to copyright protection under the copyright laws of the United
States and of other countries. The owner of the copyright rights
has no objection to the facsimile reproduction by anyone of the
patent document or the patent disclosure, as it appears in the
United States Patent and Trademark Office publicly available file
or records, but otherwise reserves all copyright rights whatsoever.
The copyright owner does not hereby waive any of its rights to have
this patent document maintained in secrecy, including without
limitation its rights pursuant to 37 C.F.R. .sctn. 1.14.
BACKGROUND OF THE INVENTION
[0005] 1. Field of the Invention
[0006] This invention pertains generally to apparatus and methods
for magnetically manipulating body structures and more particularly
to performing corrective procedures on a patient via incremental
magnetic loading.
[0007] 2. Description of Related Art
[0008] Anatomical deformities occur in the general populous in a
number of different forms and from a variety of causes. Examples of
skeletal deformities include, pectus excavatum, scoliosis, club
feet, and numerous forms of skeletal dysplasia. These conditions
are treated in a variety of different manners from braces to
surgery, with sometimes minimal efficacy.
[0009] The defect known as pectus excavatum, or funnel chest, is a
congenital anomaly of the anterior chest wall. The excavatum defect
is characterized by a deep depression of the sternum, usually
involving the lower half or two thirds of the sternum, with the
most recessed or deepest area at the junction of the chest and the
abdomen. The lower 4-6 costal or rib cartilages dip backward
abnormally to increase the deformity or depression and push the
sternum posterior or backward toward the spine. Also, in many of
these deformities, the sternum is asymmetric or it courses to the
right or left in this depression. In many instances, the depression
is on the right side.
[0010] Pectus excavatum with significant deformity occurs in
approximately 1 out of every 2000 births. The deformity may be
present at birth but is often noted after several years of age and
usually worsens during rapid growth around puberty. Because of the
pressure of the sternum and cartilages, defect also pushes the
midline structures so that the lungs are compressed from side to
side and the heart (right ventricle) is compressed. Severe lesions
have a major effect on thoracic volume and pulmonary function but
the principal motivation for repair is the deformity itself. It
does occur in families and thus, is inherited in many instances.
Other problems, especially in the muscle and skeletal system, also
may accompany this defect. In approximately 1/5 of the patients,
scoliosis is present. The regression or any improvement in this
defect rarely occurs because of the fixation of the cartilages and
the ligaments. When one takes a deep breath or inspires, the defect
is usually accentuated.
[0011] Pectus excavatum can be repaired surgically using an open
approach in which the malformed costal cartilages are resected and
the sternum forcibly held in place with a metal strut. In another
approach, described in U.S. Pat. No. 6,024,759, the sternum is
forced into a corrected position often under great tension, and
held in place with a metal strut. Both can achieve good results but
at the cost of considerable morbidity: an operation under general
anesthesia followed by a 4-7 day hospital stay required for pain
control usually by continuous epidural analgesia. Several more
weeks of moderate to severe discomfort are typical and
complications from the sternum held forcibly against the metal
strut are not infrequent. It is necessary to leave the bar in place
for a year or more before it is removed in another procedure. Total
cost usually reimbursed by third party payers averages more than
$30,000.
[0012] The problem with all currently available pectus excavatum
surgical repairs is that they attempt to achieve immediate total
correction and fixation often under considerable tension. A better
approach would be the gradual step-by-step correction of the
deformity by applying a smaller force over a longer period of
time.
[0013] Another skeletal deformity, scoliosis, is a condition in
which an individual has an abnormal spine curvature. Generally,
some curvature in the neck, upper trunk and lower trunk is normal.
However, when there are abnormal side-to-side (lateral) curves in
the spinal column, the patient is generally diagnosed as having as
scoliosis.
[0014] Orthopaedic braces are typically used to prevent further
spinal deformity in children with curve magnitudes within the range
of 25 to 40 degrees. If these children already have curvatures of
these magnitudes and still have a substantial amount of skeletal
growth left, then bracing is a viable option. The intent of
bracing, however, is to prevent further deformity, and is generally
not used to correct the existing curvature or to make the curve
disappear.
[0015] Surgery is an option used primarily for severe scoliosis
(curves greater than 45 degrees) or for curves that do not respond
to bracing. The two primary goals for surgery are to stop a curve
from progressing during adult life and to diminish spinal
deformity.
[0016] Although there are different techniques and methods used
today for scoliosis surgery, all of them involve fairly invasive
procedures with considerable patient morbidity. One frequently
performed surgery involves posterior spinal fusion with
instrumentation and bone grafting, which is performed through the
patient's back. During this surgery, the surgeon attaches a metal
rod to each side of the patient's spine by anchor's attached to the
vertebral bodies. The spine is then fused with a bone graft. The
operation usually takes several hours and the patient is typically
hospitalized for a week or more. Most patients are not able to
return to school or for several weeks after the surgery and cannot
perform some pre-operative activities for up to four to six
months.
[0017] Another surgery option for scoliosis is an anterior
approach, wherein the surgery is conducted through the chest walls
instead of entering through the patient's back. During this
procedure, the surgeon makes incisions in the patient's side,
deflates the lung and removes a rib in order to reach the spine.
The anterior spinal approach generally has quicker patient
rehabilitation, but usually requires bracing for several months
after this surgery.
[0018] Yet another medical practice in need of improvement is
anstosmosis of organs, i.e. creating an opening between two
normally separate anatomical regions or organs. Anastomosing hollow
organs together is a mainstay of surgery: vascular anastomosis,
intestinal anastomosis, urinary tract anastomosis are common
procedures in the medical practice. Restoring continuity to hollow
viscera has been a fertile realm for surgeons, and numerous
techniques have evolved in attempt to make these connections work.
The most commonly used are suture anastomosis or stapled
anastomosis. However, these techniques tend to be highly invasive
and result in significant morbidity.
[0019] For these reasons, it would be desirable to provide improved
apparatus and methods for repositioning bone structures, by
applying a corrective force to the bone structure, which could be
gradually adjusted much like orthodontic tooth braces.
[0020] It would be further desirable to provide a device that
applies a corrective force to reposition a body member without a
mechanical force that requires piercing of the skin, thereby
limiting the specter of infection and wound problems.
[0021] In addition, it would be desirable to provide a device for
repositioning bones structures having tension-sensing technology to
allow measurement of the force applied to correct all types of
asymmetric deformities and allow protection of skin against
pressure damage.
[0022] It would further be desirable to provide improved devices
and methods for minimally invasively treating pectus excavatum.
[0023] In addition, it would be desirable to provide improved
devices and methods for minimally invasively treating
scoliosis.
[0024] At least some of these objectives will be met with the
inventions described hereinafter.
BRIEF SUMMARY OF THE INVENTION
[0025] The present invention comprises apparatus and methods for
altering the position, orientation, growth or development of body
parts and organs by magnetic forces to apply a steady sustained
force over time. The invention uses magnetic force fields that may
be used to correct a number of anatomic deformities, including, but
not limited to: pectum excavetum, pectus carinatum, scoliosis, club
feet, cranial/facial anomalies or defects, skeletal dysplasias,
cartilaginous deformities/dysphasia, and joint
deformities/dysphasia. The invention may also be used to
incrementally lengthen bone or apply bone compression to promote
healing.
[0026] An aspect of the invention is an apparatus for incrementally
manipulating an internal body member of a patient. In one
embodiment, the apparatus comprises magnetic implant adapted to be
received on a location of the body member, a platform external to
the patient, and a magnetic member coupled to the platform, wherein
the magnetic member generates a magnetic force between the implant
and the platform to incrementally manipulate the body member. The
implant and external magnetic member preferably comprise a rare
earth magnet or array of rare earth magnets, and are configured to
generate an attractive or repulsive force between the implant and
the platform to reposition, reorient, deform, or lengthen the body
member.
[0027] In one aspect of the invention, the implant is adapted to be
received on a location of the sternum to treat pectus excavatum. In
this configuration the platform comprises a chest plate adapted to
be positioned exterior to the patient's chest. The magnetic member
is coupled to the chest plate to generate an attractive force
between the implant and the chest plate to incrementally reposition
the sternum.
[0028] The implant is preferably adapted to be received on a
posterior surface on the sternum. The implant generally comprises
an internal magnet and a casing to enclose the internal magnet. The
casing may be made from any rigid biocompatible material capable of
withstanding the forces of the magnet without significant
deformation, such as high-grade medical epoxy or similar material
used in the art.
[0029] In a preferred embodiment, the implant is attached to the
sternum using a plurality of sutures, wherein the sutures are
looped through a plurality of holes in the implant casing and
around the sternum to attach the implant to the posterior surface
of the sternum.
[0030] In one embodiment, the platform chest plate generally has a
concave inner surface to allow the sternum to deform outwardly from
the chest. The platform may also have an adjustable stage coupled
to the chest plate, wherein the magnetic member is mounted on the
stage. A plurality of adjustment members may be coupled to the
stage to adjust the orientation and position of the magnetic member
with the implant.
[0031] In another embodiment of the invention, a plurality of
sensors and a strain gauge may be coupled to the chest plate, with
the strain gauge measuring the force applied to one or more
locations on the platform.
[0032] In most cases the attractive force of the magnets support
the chest plate to the patient's chest. However, a chest strap may
also be used to support the chest plate to the patient's chest.
[0033] In another aspect of the invention, the implant is adapted
to be received on a location of a vertebrae of the patient's spine
to treat scoliosis or other spinal disorders. In this
configuration, the platform comprises a support adapted to be
positioned exterior to the patient's torso. Generally, the magnetic
member is coupled to the support such that the magnetic member
generates a magnetic force between the implant and the plate to
incrementally reposition the spine. The magnetic member and the
implant may be configured to generate an attractive or repulsive
force between the implant and the magnetic member.
[0034] Where the patient has an abnormal curvature of the spine,
the implant is preferably configured to be received on a vertebrae
located at an apex of the abnormal curvature. The support may be
positioned such that the magnetic force incrementally repositions
the spine to remove the abnormal curvature. The implant and the
magnetic member may also be configured to impart a torsional force
on the vertebrae to incrementally reorient the spine.
[0035] In one embodiment, a bone screw is threaded into the
vertebrae to rigidly couple the implant to the vertebrae.
[0036] According to another aspect of the invention, a method for
incrementally repositioning an internal body member of a patient
comprises installing a magnetically responsive implant to a
location on the internal body member; positioning a platform
exterior the patient to generate a magnetic field, the magnetic
field effecting an magnetic force between the implant and the
platform, and manipulating the body member to a first state as a
result of the generated magnetic force.
[0037] In a preferred embodiment, the method also includes
adjusting the magnetic field to one or more intermediate settings,
manipulating the body member to one or more intermediate state as a
result of the attractive force generated by the one or more
adjusted magnetic field settings, adjusting the magnetic field to a
final setting; and manipulating the body member to a final state as
a result of the attractive force generated by the final magnetic
field setting.
[0038] The step of generating a magnetic field may comprise
generating an attractive or repulsive force between the implant and
the platform. The body member may be manipulated by repositioning
the body member to a first position, deforming the body member to a
first shape, or lengthening the body member to a first length.
Repositioning the sternum may comprise deforming one or more
cartilages connected to the sternum as a result of the attractive
force, or deforming the shape of the sternum as a result of the
attractive force.
[0039] In one aspect of the invention, manipulating a body member
comprises manipulating the patient's sternum. In such a
configuration, installing a magnetically responsive implant
comprises attaching an internal magnet to a posterior location on
the sternum. Positioning a platform is achieved by manipulating a
stage housing an external magnet, the stage being coupled to a
chest plate. A plurality of adjustment members may be used to
adjust the position and orientation of the external magnet with
respect to the internal magnet, thereby effecting the magnitude and
direction of the magnetic force between the platform and the
implant.
[0040] In one aspect of the invention, manipulating a body member
comprises manipulating a vertebrae of the patient. In such a
configuration, installing a magnetically responsive implant
comprises attaching an internal magnet to a location on the
vertebrae. The vertebrae may be manipulated by adjusting the
magnetic field between the implant and the platform to
incrementally reposition the spine. The magnetic field may be
adjusted to generate an attractive or repulsive force between the
implant and the platform to incrementally reposition the spine.
Where the spine has an abnormal curvature, the implant is installed
on a vertebrae located at an apex of the abnormal curvature. In
such a configuration the vertebrae may be manipulated to
incrementally reposition the spine to remove the abnormal
curvature. A torsional force may also be imparted on the vertebrae
to incrementally reorient the spine.
[0041] In a preferred embodiment, installing the implant comprises
boring a hole in a pedicle of the vertebrae, and threading a
pedicle screw into the pedicle, the pedicle screw configured to
rigidly couple the implant to the vertebrae.
[0042] In another aspect of the invention method is disclosed for
performing a pectus excavatum procedure on a patient having a
deformed sternum. The method comprises attaching a magnetically
responsive implant to a location on the sternum, and positioning a
chest plate exterior the patient's chest to generate a magnetic
field, wherein the magnetic field effects an attractive force
between the implant and the chest plate. The implant generally
comprises a first magnet housed in a biocompatible casing.
[0043] The first magnet may be attached to a posterior surface on
the sternum by incising a section of the patient's skin over the
patient's sternum, separating the xiphoid process from the sternum,
dissecting under the sternum and securing the first magnet to the
posterior surface of the sternum. One method for securing the first
magnet to the sternum comprises drilling a plurality of holes from
an anterior location on the sternum to a posterior location on the
sternum, and looping a plurality of sutures through the holes in
the sternum and through a plurality of holes in the casing housing
the first magnet.
[0044] According to yet another aspect of the invention, a method
for incrementally repositioning a patient's sternum is disclosed.
The method comprises installing a magnetically responsive implant
to a location on the sternum, positioning a chest plate exterior
the patient's chest to generate a magnetic field, wherein the
magnetic field effects an attractive force between the implant and
the chest plate, repositioning the patient's sternum to a first
position as a result of the generated magnetic force, manipulating
the magnetic field to one or more intermediate settings,
repositioning the patient's sternum to one or more intermediate
positions as a result of the attractive force generated by the one
or more manipulated magnetic field settings, manipulating the
magnetic field to a final setting, and repositioning the patient's
sternum to a final position as a result of the attractive force
generated by the final magnetic field setting.
[0045] According to a further aspect of the invention, an apparatus
for incrementally manipulating an internal body member of a patient
comprises a magnetically responsive implant adapted to be received
on a location of the body member, the implant responsive to a
magnetic field, and means for generating an attractive force
between the implant and a platform external to the patient to
manipulate the body member. The device may further comprise means
for adjusting the magnitude and direction of the magnetic force
applied between the platform and the implant. The device also has
means for securing the implant to a location on the body
member.
[0046] In a preferred embodiment, the apparatus has a means for
detecting the force applied to the platform at a plurality of
locations on the platform, such as a strain gauge. The strain gauge
may also configured to measure the force at a plurality of
locations on the platform.
[0047] According to yet another aspect of the invention, a method
for incrementally repositioning an internal body member of a
patient comprises installing a magnetically responsive implant to a
location on the internal body member, positioning a platform
exterior the patient to generate a magnetic field, the magnetic
field effecting a magnetic force between the implant and the
platform, measuring the magnetic force between the implant and the
platform; adjusting the platform to tune the magnetic force applied
between the implant and the platform; and manipulating the body
member to a first state as a result of the generated magnetic
force.
[0048] In an alternative embodiment of the present invention, an
apparatus for manipulating one or more internal body members is
disclosed. The apparatus comprises a first elongate member having a
driving end and a receiving end, wherein the receiving end of the
first member having a recess extending toward the driving end. The
apparatus also has a second elongate member having a driving end
and a receiving end, the receiving end of the second member having
a recess extending toward the driving end. The second member is
sized such that the receiving end of the second member is slideably
received within the receiving end of the first member. The
apparatus further comprises a first magnet coupled to the first
member, and a second magnet coupled to the second member, wherein
the first and second magnets are configured to repel each other
such that an outward magnetic force is generated to the driving
ends of the first and second members. The first and second magnets
may be positioned within the recesses to change the magnitude of
the force generated between the first and second magnets. The first
and second magnets may also be configured such that rotation of the
first magnet with respect to the second magnet changes the
magnitude of the force generated between the first and second
magnets.
[0049] According to another aspect of the invention, an apparatus
for intermittently delivering a force to a body member to
incrementally manipulate the body member comprises an implant
adapted to be received on a location of the body member, the
implant responsive to a magnetic field, a platform external to the
patient, and a magnetic member coupled to the platform, wherein the
magnetic member generates a magnetic force between the implant and
the platform to incrementally manipulate the body member, the
magnetic member and the implant configured such that rotation of
the magnetic member varies the magnetic force between the implant
and the platform.
[0050] Yet another aspect is a method for auto-anastomosing a
region of the body. The method includes delivering a first magnetic
member to a first location in the body adjacent the region, and
locating a second magnetic member adjacent the region opposite from
the first magnetic member, such that the region is disposed in
between the first magnetic member and the second magnetic member.
An attractive force is generated between the first magnetic member
and the second magnetic member to compress tissue in the region
between the first magnetic member and the second magnetic member.
This compressive force results in necrosis of the tissue in the
region between the first and second magnetic members such that the
tissue surrounding the necrosed tissue heals together to form an
anastomosis.
[0051] In a preferred embodiment of the present aspect, the method
further includes removing the necrosed tissue and the first and
second magnetic members from the region. Often, the necrosed tissue
and the first and second magnetic members are removed from the
region via flow of natural bodily functions. If need be, the first
and second magnetic members may also be retrieved from a location
at or near the region.
[0052] In another embodiment, the region comprises tissue occupied
by first and second internal viscera segments in the body. The
first magnetic member is delivered into the first viscera segment,
and the second magnetic member is correspondingly delivered to the
second viscera segment at a location in proximity to the first
magnet to generate a compressive force on the tissue in between
first and second viscera segments. Subsequently, the anastomosed
region creates a fistula between the first and second viscera
segments.
[0053] In some embodiments, the first viscera segment is located in
a first viscera, and the second viscera segment is located in a
location in a second viscera in proximity to the first viscera.
Alternatively, the first viscera segment and second viscera segment
are separate sections of the same viscera.
[0054] The viscera may be any hollow organ or lumen where
anastomosis is desired. In a preferred embodiment, the method is
performed on an organ or lumen, or plurality of organs or lumens,
in the gastrointestinal or urinary tracts, such as the small
intestines, stomach, colon, ureters, renal pelvis, bladder,
urethra, etc.
[0055] In another embodiment, the treated region comprises tissue
occupied by a visceral wall and surrounding tissue between the
visceral wall and an external surface on the body. The first
magnetic member is delivered to the visceral wall, and the second
magnetic member is located adjacent the external surface in
proximity to the first magnetic member to create a stoma between
the internal visceral wall and the external surface.
[0056] Another aspect of the invention is a system for
auto-anastomosing a region of the body. The system includes a first
magnetic member configured to be delivered to a location in the
body adjacent the region, and a second magnetic member configured
to be located adjacent the region opposite from the first magnetic
member such that the region is disposed in between the first
magnetic member and the second magnetic member. The first and
second magnetic members are configured to generate an attractive
force to compress tissue in the region between them. The tissue in
the region necroses as a result of the compressive force such that
tissue surrounding the necrosed tissue heals together to form an
anastomosis.
[0057] The system may further include a catheter that is configured
to deliver the first magnetic member to the location adjacent the
region and release the first magnetic member at the location.
[0058] In a preferred embodiment, the first magnetic member
comprises a biocompatible casing, such as a titanium enclosure, or
epoxy coating.
[0059] Yet another aspect is an apparatus for auto-anastomosing a
region of the body comprising a first visceral wall. The apparatus
comprises a first magnetic member configured to be delivered to a
first location at the first visceral wall, the first location being
adjacent the region, and a second magnetic member configured to be
positioned at a second location adjacent the region opposite from
the first magnetic member such that the region is disposed in
between the first magnetic member and the second magnetic member.
The first and second magnetic members are configured to generate an
attractive force to compress and necrose the tissue in the region
between them, such that tissue surrounding the necrosed tissue
heals together to form a fistula from the first location to the
second location.
[0060] In a preferred embodiment, the region further comprises
tissue occupied by a second internal viscera wall in the body, and
wherein the second magnetic member is configured to be delivered to
the second visceral wall at a the second location to generate a
compressive force on the tissue in the tissue in between first and
second visceral walls.
[0061] Alternatively, the region comprises abdominal tissue in
between the visceral wall and an external surface on the body,
wherein the second magnetic member is configured to be positioned
adjacent the external surface at the second location such that the
fistula creates a stoma connecting the internal visceral wall to
the external surface.
[0062] Additionally, the apparatus may also have an intermediate
magnetic member configured to be positioned in the abdominal tissue
between the first magnetic member and the second magnetic member to
generate a compressive force between it and both the first magnetic
member and the second magnetic member.
[0063] Further aspects of the invention will be brought out in the
following portions of the specification, wherein the detailed
description is for the purpose of fully disclosing preferred
embodiments of the invention without placing limitations
thereon.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
[0064] The invention will be more fully understood by reference to
the following drawings which are for illustrative purposes only,
and where like reference numbers denote like elements:
[0065] FIG. 1 is a schematic view of a human sternum with an
implant according to the present invention installed under the
sternum.
[0066] FIG. 2 is a cross-sectional schematic view of the platform
of the present invention installed over a patient's chest and an
implant installed under the sternum.
[0067] FIG. 3 shows an embodiment of the implant of the present
invention.
[0068] FIG. 4 is a side view of the implant of FIG. 3.
[0069] FIG. 5. is a schematic view of a sternum.
[0070] FIG. 6. is a cross-sectional view of a sternum with the
xiphoid separated from the sternum body.
[0071] FIG. 7 is an implant drill guide according to the present
invention.
[0072] FIG. 8 shows the drill guide of FIG. 7 installed over the
sternum.
[0073] FIG. 9 illustrates a preferred method for installing a
portion of the implant to the posterior surface of the sternum.
[0074] FIG. 10 illustrates a portion of the drill guide of FIG. 7
positioned over a second location on the sternum.
[0075] FIG. 11 illustrates a preferred method for installing a
second portion of the implant to the posterior surface of the
sternum.
[0076] FIG. 12 is another view of the method of FIG. 11.
[0077] FIG. 13 shows the implant according to the present invention
installed on the posterior surface of the sternum.
[0078] FIG. 14 is a view of the underside of an embodiment of the
platform according to the present invention.
[0079] FIG. 15 is a view of the top of the platform of FIG. 14.
[0080] FIG. 16 is a side view of another embodiment of the platform
of the present invention.
[0081] FIG. 17 is a side of another embodiment of the platform of
the present invention.
[0082] FIG. 18A is an anterior view of the human spine.
[0083] FIG. 18B is a lateral view of the human spine.
[0084] FIG. 19A-D illustrate various abnormal curvatures of the
spine due to scoliosis.
[0085] FIG. 20 illustrates abnormal rotation of the vertebrae of
the spine as a result of scoliosis.
[0086] FIG. 21 illustrates another embodiment of the invention for
treating scoliosis.
[0087] FIG. 22 illustrates an alternative embodiment for delivering
a pulsed magnetic field to a body member.
[0088] FIG. 23 is a schematic view of an alternative embodiment for
delivering a repulsive force to a body member.
[0089] FIG. 24 is a schematic view of the device of FIG. 23 with a
fluid pump.
[0090] FIG. 25 illustrates an alternative embodiment of a repulsion
device incorporating a mechanical jackscrew.
[0091] FIG. 26 illustrates an alternative embodiment of a repulsion
device incorporating an electric jackscrew.
[0092] FIG. 27 is a schematic diagram for a system for performing
auto-anstomosis between two internal organs using magnetic ring
implants in accordance with the present invention.
[0093] FIG. 28 is a schematic diagram for a system for performing
auto-anstomosis between two internal organs using magnetic disc
implants.
[0094] FIG. 29 is another view of the system of FIG. 27 showing the
magnetic implants concentrically aligned.
[0095] FIG. 30 shows the system of FIG. 27 with the magnets
collapsing the visceral walls.
[0096] FIG. 31 is a view of the system shown in FIG. 27 with the
tissue between the magnets cut out.
[0097] FIG. 32. illustrates the system of FIG. 27 after the tissue
between the magnets has necrosed and fallen out, with accompanying
anastomosis and fistula.
[0098] FIG. 33 illustrates the system of FIG. 27 after the magnets
have fallen out of the fistula.
[0099] FIG. 34 illustrates an exemplary gastrointestinal tract.
[0100] FIG. 35 illustrates a patient with duodenal atresia.
[0101] FIG. 36 illustrates a schematic diagram of the system of the
present invention used to treat the duodenal atresial.
[0102] FIG. 37 illustrates an exemplary urinary tract.
[0103] FIG. 38 shows a schematic diagram of a system for creating
an ostomy using an internal magnet and external magnet in
accordance with the present invention.
[0104] FIG. 39 illustrates a stoma in the abdominal wall created
after implementation of the system of FIG. 38.
[0105] FIG. 40 illustrates the system of FIG. 38 using an
intermediate internal magnet.
DETAILED DESCRIPTION OF THE INVENTION
[0106] Referring more specifically to the drawings, for
illustrative purposes the present invention is embodied in the
apparatus and methods generally shown in FIG. 1 through FIG. 17 and
FIGS. 21-26 and 27-40. It will be appreciated that the apparatus
may vary as to configuration and as to details of the parts, and
that the methods may vary as to the specific steps and sequence,
without departing from the basic concepts as disclosed herein.
[0107] The present invention utilizes a system in which a small
magnet is implanted in cooperation with an internal body member to
apply a corrective force to the body member by virtue of its
attraction to an adjustable magnet in an external device that is
comfortable and cosmetically pleasing.
[0108] Small rare earth metal magnets can produce considerable
force and can be manipulated in terms of size, shape and position.
This force can be used to alter growth and development of skeletal
structure and soft tissue. The biology of tissue response to force
has been well studied. Clinical application of this powerful
biologic principle has been limited by the difficulties of applying
force through external bracing or through internal pins manipulated
by external devices (e.g., bone lengthening through distraction
osteogenesis). Magnetic force fields can be used to apply force to
implanted magnets attached to an internal structure without
violating the skin and soft tissue. The magnetic force field can be
manipulated externally to adjust the direction, strength and speed
at which the deformity is corrected.
[0109] 1. Pectus Excavetum
[0110] FIGS. 1-16 illustrate a preferred embodiment of the
invention relating to the correction of pectus excavetum. FIG. 1
illustrates a schematic, anterior view of a human sternum 20. The
sternum 20 is an elongated, flatted bone, forming the middle
portion of the anterior wall of the thorax. The sternum 20
generally consists of three parts: the manubrium 22, which at its
upper end supports the clavicles (not shown); the body or gladiolis
24, which interfaces at its upper end with the lower end of the
manubrium 22, and the xiphoid process 26, which interfaces at its
upper end with the lower end of the gladiolis 24 at junction 30.
The margins of sternum 20 articulate with the first of seven pairs
of ribs 28.
[0111] As shown in FIG. 1 and illustrated as a cross-sectional view
of a corrected patient's chest in FIG. 2, a magnetic substernal
implant 42 may be installed on the posterior surface 32 the body 24
of the sternum 20, just above the xiphoid process 26. Illustrated
in greater detail in FIG. 3, the implant 42 preferably comprises a
rare earth magnet 90, or an array of rare earth magnets housed in
casing 92. The casing 92 may comprise any biocompatible material
such as medical grade epoxy, titanium or suitable material used in
the art. Casing 92 preferably has mounting holes 56 for fixation at
each corner. The casing 92 may also have a plurality of protrusions
94 to enhance the attachment of the implant 42 with the sternum
20.
[0112] The magnetic implant 42 is sized to fit comfortably behind
the sternum. An exemplary implant may 3 inches long, 21/2 inches
wide and 3/16 thick. However, the size of the implant may vary
according to patient anatomy.
[0113] FIG. 2 and FIGS. 5-13 illustrate an exemplary method of
surgically installing the implant 42. A 3 cm substernal transverse
incision 58 is made through the patient's skin 36. The ziphoid
process 26 is then separated from the lower sternum body 24 and a
pocket is bluntly dissected behind the posterior surface 32 of the
sternum, as illustrated in FIG. 6.
[0114] The implant 42 is attached to the posterior surface of the
sternum with sutury passed through the holes 112 in the sternum
illustrated in FIG. 2. Using laparoscopic or arthroscopic
visualization, a drill guide 100 is inserted and positioned over
the proximal end of the sternum body 24, as shown in FIGS. 7 and 8.
A small stab wound is made into skin 36, and the drill sleeve 102
is inserted through the guide 100. The sternum 20 is then drilled
under direct visualization to bore one or more distal bores 106
from the anterior surface 34 of the sternum through to the
posterior surface 32. Distal bores 106 preferably line up with the
corresponding mounting holes 56 in casing 92.
[0115] Referring now to FIG. 9, a distal suture 108 is looped
through one of the mount holes 56 of casing 92. The distal suture
108 preferably comprises a heavy braided suture commonly used in
the art, e.g. #2 or #5 ticron. The suture is then fed under the
sternum 20 and a suture retriever 110, such as a Hewson type, is
used to pull the distal suture 108 through the corresponding distal
bore 106 in the sternum body 24 and the anterior skin stab wound.
The process is repeated for the second corner of the distal end of
the casing 92.
[0116] Referring now to FIG. 10, the proximal end 114 of skin 36
and subcutaneous tissues from the anterior sternum proximal to the
sterno-xiphoid junction 58 are pulled back to expose the proximal
end of the sternum body 24. The drill guide 100 is moved
transversely along the sternum body 24 to the exposed portion of
the sternum under proximal end 114. Once sufficient exposure is
obtained, one or more proximal bores 112 are drilled under direct
vision through the sternum anteriorly-to-posteriorly, thus
providing anchoring points for all corners of the casing 92.
[0117] Now referring to FIGS. 11 and 12, a proximal suture 116 is
looped through one of the mount holes 56 on the proximal end of
casing 92. The suture is then fed under the sternum 20 and suture
retriever 110 is used to pull both ends of the proximal suture 116
through the corresponding proximal bore 112 in the sternum body 24.
The process is repeated for the second corner of the proximal end
of the casing 92.
[0118] As seen in FIG. 12, both sets of proximal and distal sutures
116, 108 are pulled to guide the implant 42 up behind the sternum
20 and maintain the apposition of the casing 92 to the sternum 20
with traction on the sutures.
[0119] Referring now to FIG. 13, the proximal sutures 116 are tied
down firmly over the sternal bone bridge to secure the implant 20
to the proximal surface 32 of the sternum. Under direct vision, the
process is repeated for the distal sutures 108.
[0120] Although FIGS. 9-13 illustrate a preferred embodiment using
suture to fasten the implant 42 to the sternum 20, it is
appreciated that any number of different fastening means commonly
known in the art may be used to secure the implant 42. For example,
bolts (not shown) may be passed through bores 106, 112, threaded
into threaded mounting holes 56 of casing 92 and torqued down to
secure the implant 42 to the posterior surface 32 of the sternum
20. Alternatively, the implant may be fastened to either the
posterior or anterior sides of the sternum via cables that wrap
around the sternum. In this configuration, since the implant is
closer to the platform, the internal magnetic member may be any
magnetically responsive material, such as an iron plate with
biocompatible coating (e.g. titanium).
[0121] Surgical placement generally requires a brief outpatient
general anesthesia. The procedure takes about 30 minutes and
requires minimal post-operative analgesia.
[0122] FIGS. 2 and 14-17 illustrate several embodiments of an
external magnet platform of the present invention for treating
pectus excavatum. FIGS. 14 and 15 show an embodiment having a
platform 40 configured to be worn over a patient's chest. Platform
40 comprises a chest plate 44 sized according to the patient's
anatomy. Generally, a mold is made of the individual's chest
deformity. From this the desired end point position of the sternum
and chest wall shape are molded to create the chest plate 44. FIG.
14 is a bottom view of platform 40, showing the underside 78 of
chest plate 44. In addition to being contoured to comfortably rest
on the patient's chest, the underside 78 of the chest plate is cut
away to create cavity 68 that allows the chest to expand outward as
a result of treatment.
[0123] In a first configuration, an external magnet 48 is hung from
the underside 78 of the chest plate 44 by a plurality of adjustment
cables 62. External magnet 48 is preferably a rare earth magnet, or
array of rare earth magnets. The external magnet has an adjustable
stage, or mounting plate 50, which has a plurality of holes 70 to
secure cables 62. As illustrated in FIGS. 14 and 15, the magnet 48
is hung with 4 cables. However, other configurations, such as a
three cable design (not shown), may also be used. The cables 62 are
coupled to the chest plate via adjustment members 54. Cables 62
lead from the magnet plate 50 out to the exterior surface 46 and
back through to the underside of the chest plate via through holes
64 to terminate at adjustment member 54. One or more biasing
springs 52 may be imposed between the chest plate 44 and the magnet
48, creating a tensile force on cables 62 so that the magnet is
biased to the furthest orientation away from the chest plate 44
that is allowed from the cables' length.
[0124] By turning adjustment member 54 from the top of the chest
plate illustrated in FIG. 15, the cable 62 may be shortened,
thereby advancing one corner of the magnet plate 50 upward toward
the chest plate 44. By rotating the adjustment member in the
opposite direction, the cable is extended, thereby advancing one
corner of the magnet plate 50 toward from the patient's chest and
away from the chest plate 44. When all the adjustment members are
moved the same increment, the magnet will translate toward or away
from the patient's chest in the Z axis (see FIGS. 2 and 14). The
magnet may also be rotated angle .theta. about the X or Y axis by
manipulating the adjustment members 54 to lengthen or shorten one
or more cables 62 with respect to the remaining cables.
[0125] The external magnet 48 and the implant magnet 90 are
configured so that their opposite poles face each other, thereby
generating an attractive force between the two magnets. By
manipulating the distance of the external magnet 48 from the chest
plate 44 in the Z direction, the amount of force applied to the
internal magnet can be incrementally tuned or adjusted. By
manipulating the orientation of the external magnet 48 with respect
to the chest plate 44 in the X and Y directions, the direction of
force applied to the internal magnet can be incrementally
adjusted.
[0126] The chest plate 44 is preferably comprised of a rigid
material, such as a rigid thermoplastic or polymer or steel
reinforced polymer that does not deform as a result of the magnetic
forces, allowing external magnet 48 to remain stationary with
respect to the patient's chest. As a result of the constant force
applied from the external magnet 48, the implant 42 imposes a
corrective outward force F on the posterior surface 32 of the
sternum 20. This outward force incrementally repositions/deforms
the sternum 20 to move outward from the patient's chest cavity. By
adjusting the angle of the external magnet in the X and Y
directions, the force generated on the implant 42 may be directed
to orient the sternum in the X and Y axes as well to correct
asymmetric lesions.
[0127] An initial adjustment of the platform is made after the
implant is placed in the outpatient surgical procedure. When the
sternum 20 and implant 42 move toward the external magnet 48, the
force generated between the magnets increases. If this force
becomes too great and becomes uncomfortable for the patient, the
magnet may be retracted toward the chest plate 44, thereby
returning the magnetic force to the optimum comfort level for the
patient. This process may be repeated for a number of intermediary
steps, until the sternum 20 is gradually repositioned and/or
deformed toward the desired final position and orientation.
[0128] The platform 40 may also include a strain gauge 74, or other
force measuring means, to accurately determine the force being
generated by the magnets. Strain gauge 74 may be connected via lead
wires 76 to various points on the magnet plate 50 so that the
pressure on each quadrant of the magnet may be accurately assessed.
Strain gauge 74 may also comprise an LCD display (not shown) so
that the patient or physician may readily assess whether the
external magnet 48 is properly oriented, and adjust the magnet if
need be.
[0129] The platform 40 is held in place by the magnetic pull
between the two magnets, and in addition may be secured in place
with a loose elastic band (not shown) around the chest. The
principal force holding the platform 40 in place is the magnetic
field itself. The patient may adjust the platform 40 to comfort and
thus ensure against pressure damage to soft tissue. The patient may
be taught to how to manipulate the external magnet 48 up and down
to adjust and balance the force pulling the sternum 20 outward.
[0130] To provide extra comfort to the patient, and prevent the any
unwanted manipulation of the adjustment members, a cover, such as
that shown in FIG. 16, may be provided to cover the chest plate
while the platform is being worn.
[0131] A preferred embodiment of the invention incorporating a
bridged platform 200 is illustrated in FIGS. 16 and 17. Platform
200 has a chest plate 202 having a support 204 with opening 206 at
it center. Chest plate 202 and support 204 may be separate pieces
fastened together as shown in FIG. 16, or one integrated piece (not
shown). Load member 208 is positioned in the opening 206 of support
204, and is bridged by a plurality of thin beam force sensors
214.
[0132] Load member 208 has a plurality of adjustment members 210
that retain magnet plate 50 and magnet 48 via a hanging means 212.
Adjustment member 210 comprises an in-line screw, such as a
jack-screw, lead screw, ball screw, or the like, which is hollowed
out to support hanging means 212. As shown in FIGS. 16 and 17,
hanging means 212 comprises a ball chain, but may also comprise a
cable, wire, or the like. Alternatively, adjustment members 210 may
comprise extended screws (not shown) that terminate a ball joint in
magnet plate 50.
[0133] Adjustment members 210 may be manipulated to lower or raise
the magnet 48, or adjust the angle of the magnet, as described in
the embodiment of FIGS. 14 and 15. By turning screw 210 clockwise,
one quadrant of the external magnet 48 may be precisely lowered to
change the angle of the external magnet 48 with respect to the
patient's chest, thereby changing the direction of the force
applied to the implant 42. By turning all the screws the same
clockwise increment, the magnet is lowered to generate a larger
attractive force on the implant. Correspondingly, counter-clockwise
rotation raises the external magnet to lower the attractive force
on the implant 42.
[0134] When the platform is placed against the patient's chest, the
attractive force between the implant 42 and the external magnet
generates a load on load member 208. This load is sensed at all
four quadrants by the thin beam force sensors 214. Readings from
the sensors 214 are received by a force measuring means, such as
the strain gauge 74 illustrated in FIG. 15, to provide accurate
data on the force applied at each quadrant of the external magnet.
This enables the treating physician or patient to accurately assess
corrective the force being applied to the sternum, and modify the
force if not at the desired level.
[0135] FIG. 17 illustrates an alternative embodiment having a
platform 220 wherein the adjustment member comprises a clasp 222
for incrementally adjusting the extended length of ball chain 212,
which is attached to each corner of the external magnet cradle 224.
By changing the position at which the clasp 222 engages the ball
chain 212 (similar to adjusting a necklace of bracelet), the height
at any one quadrant of the magnet 48 may be changed with respect to
the patient's chest to vary the force or direction of the
corrective magnetic field. Chest plate 202 and cradle 204 may also
have a layer of padding 226 to provide further comfort for the
patient.
[0136] Over time, the steady gradual force applied to the sternum
stretches the ligaments connecting the sternum 20 to the ribs. The
sternum 20 itself may also deform as a result of the magnetic
forces. The result is a reoriented and/or repositioned sternum
without the characteristic depression of the pectus excavatum
deformity.
[0137] As the sternum 20 moves closer to the external magnet 48,
the patient or physician will typically readjust the position of
external magnet 48 farther up into the chest plate. This is easily
accomplished by adjusting the length of the four ball chains that
suspend the magnet cradle 224.
[0138] 2. Scoliosis
[0139] FIGS. 18A and 18B illustrate the curvature of a normal spine
300. The spine is relatively straight in the sagittal plane 302 and
has a double curve in the coronal plane 304. As shown below, the
thoracic section 308 of the spine is convex posteriorly and the
lumbar section 306 of the spine is convex anteriorly. Normally
there should be no lateral curvature of the spine about the
saggital plane 302.
[0140] Scoliosis is a deformity that generally comprises by both
lateral curvature and vertebral rotation. FIGS. 19A-D illustrate
various forms of abnormal lateral curvature of the spine. FIG. 19A
shows abnormal thoracic curvature 310. FIG. 19B shows abnormal
thoracolumbar curvature 312. FIG. 19C shows abnormal lumbar
curvature 314. Finally, some cases involve a double curvature of
the spine, as shown in FIG. 19D shows abnormal thoracic
curvature.
[0141] FIG. 20 illustrates rotation of the spine and corresponding
effect on the rib cage 332 s a result of scoliosis. As the disease
progresses, the vertebrae 330 and spinous processes in the area of
the major curve rotate toward the concavity of the curve. As the
vertebral bodies rotate, the spinous processes deviate more and
more to the concave side and the ribs follow the rotation of the
vertebrae. The posterior ribs on the convex side 336 are pushed
posteriorly, causing narrowing of the thoracic cage and the
characteristic rib hump seen in thoracic scoliosis. The anterior
ribs on the concave side 334 are pushed laterally and
anteriorly.
[0142] Now referring to FIG. 21, a schematic view of external
platform 350 is illustrated with implant 340 installed on vertebrae
330 of the spine. Vertebrae 330 is preferably located at the apex
320 of the abnormal curvature shown in FIGS. 19A-D. In a preferred
embodiment implant 340 is anchored to vertebrae 330 via a bone
screw 336. Screw 336 may be threaded into a bore 334 in the pedicle
332 of the vertebrae according to commonly used procedures for a
variety of spinal conditions, including degenerative disc disease
and scoliosis. Examples of such systems are disclosed in U.S. Pat.
Nos. 6,648,915; 6,010,503; 5,946,760; 5,863,293; 4,653,481, etc.,
the entire disclosures of which are incorporated herein by
reference.
[0143] Once pedicle screw 336 is installed, internal magnet 342 may
be fastened to screw 336 via magnet casing 338 and nut 346.
Following the same procedure, a second internal magnet 344 may also
be installed on the pedicle on the opposite side of implant
340.
[0144] After installation of implant 340, external platform 350 may
be placed on the patient's back 366 adjacent to the installed
implant. Platform may be retained to the torso of the patient by a
strap the circles the patient's waist or chest at the elevation of
the implanted vertebrae 330. Platform 350 comprises a support 352
that adjustably holds first external magnet 360. First external
magnet 360 is hung inside recess 364 by a plurality rods 354, which
are fastened to external mounting plate 358 housing magnet 360. The
angle and height of magnet 360 may be incrementally adjusted by
adjustment member 356.
[0145] As illustrated in FIG. 21, external magnet 360 and internal
magnet 342 may be positioned with facing positive poles (or facing
negative poles) to generate a repulsive force between the platform
350 and the implant 340. The resulting magnetic force creates a
rotational moment R on the vertebrae 330 to incrementally reorient
the vertebrae 330 and diminish the abnormal rotation angle .beta..
As vertebrae 330 rotates to a more normal orientation, the rest of
the vertebrae of the spine follow.
[0146] If a second internal magnet 344 is installed opposite
internal magnet 342, a second external magnet 362 may be positioned
opposite internal magnet 344. As shown in FIG. 1, the opposing
magnets may be positioned to generate an attractive force, thereby
increasing the magnitude of the rotational moment R on the
vertebrae.
[0147] In addition to effecting rotation of the spine, platform 350
may be oriented to correct for lateral curvature of the spine. By
placing the platform 350 to the line up to the left of the
implants, as shown in FIG. 21, a translational force T is created
on the vertebrae 330 as a result of the attractive force between
the second external magnet 362 and second internal magnet 344. In
this configuration, external magnet 360 may be removed to increase
the attractive force. The platform 350 may be incrementally
repositioned to continue translation of the vertebrae 330.
[0148] 3. Other Applications
[0149] Variations of the above embodiments could be use to
gradually correct a variety of deformities. For example, pectus
carinatum (a deformity of the chest involving a sternal protrusion)
may be treated with the embodiments shown in FIGS. 14-17 and
orienting the magnets to apply a repulsive rather than attractive
force.
[0150] In another alternative embodiment, which may be beneficial
for soft tissue deformities, a magnetic force discontinuously
applied in order to accommodate blood flow to the tissue. For
example, the force may be applied for a period of time (e.g. a
minute) and then taken off for another period of time (applied in a
pulsed fashion) in order to let blood flow back to the tissue being
"reformed". In one embodiment illustrated in FIG. 22, a pulsed
force field is generated by rotation of the external magnet 402
with respect to fixed internal magnet 402. The magnets may have
magnetized quadrants 404 that repel/attract or become neutral upon
a 90 degree rotation with respect to each other to achieve tension
alternating with relaxation. In an alternative embodiment, the
external magnet is moved closer and then farther from the internal
magnet by rotating it on a cam (not shown).
[0151] In addition to magnetic force fields configured to
manipulate body members by attraction of two magnets (e.g. the
device above for repair of pectus excavatum), the magnets may be
configured to provide a repulsive force (e.g. a magnetic Elizeroff
to lengthen bone). In the embodiment illustrated in FIG. 23,
internal repulsion device 410 comprises first member 414 partially
encased in second member 412, wherein first member 414 is allowed
to slide inside second member 412. Each member has a corresponding
internal magnet 416, 418 which are configured to repel each other,
thus forcing first member 414 to separate from second member 412 to
form a "magnetic spring" to distance anatomy located on ends 420
and 422. The repulsive force may be varied by adjusting the
position of magnets 418 and 416 away from ends 420 and 422.
[0152] Repulsion device 410 may be used in a variety of
applications where gradual force may be applied to reposition or
deform one or more body members. For example, device 410 may be
disposed such that ends 420 and 422 are attached to two separate
locations of a bone to lengthen or alter the shape of the bone.
[0153] In an alternative embodiment illustrated in FIG. 24,
repulsion device 430 may be used having reservoir 434 and pump 436.
Pump 436 may be positioned underneath the patient's skin 438, such
that fluid may be directed through lead line 440 to reservoir 434
in second chamber 432. The pump may be used to increase the volume
of reservoir 434, thereby distancing magnet 416 away from end 420
to incrementally increase the repulsive force between 416 and
418.
[0154] In another alternative embodiment illustrated in FIG. 25,
repulsion device 450 comprises a mechanical jackscrew 470. The
device has a first member 452 and second member 454 that apply a
repulsive force to attachment points 456 and 458 that may be
attached to one or more body members. Rotary magnet coupling 468
has an internal magnet 474 under the patient's skin 476 and a
corresponding external magnet 472.
[0155] The magnets are polarized such that rotation of the external
magnet 472 causes a proportional rotation in external magnet 474,
which in turn rotates flexible shaft 478. Rotation of flexible
shaft 478 is transferred to rotation of screw 462 located on first
member 452 via worm gear 460. Nut 466 is attached to second member
454 and is threaded to screw 462 such that rotation of screw 462
causes the first member 452 to separate from 454. Additional force
and separation may be achieved by further rotation of external
magnet 474. Springs 464 may optionally be employed to create an
additional preload between the first and second members.
[0156] FIG. 26 illustrates another alternative embodiment of a
repulsion device 500 having an electric jackscrew. Control box 504
controls rotation of magnetic coupling 502. A signal is sent via
wire 510 to electronics 512 to control electric motor 514, which
drives rotation of screw 518 through gear reduction 516. Thus, a
repulsive force may be incrementally applied to separate first
member 524 from second member 522.
[0157] 4. Fistula and Auto-Anastomosis
[0158] In many situations, it is desirable to have two segments of
hollow viscera to be brought in continuity by creating a fistula
between them. Stategic placement of magnets in accordance with the
present invention may be used to create an auto-anastomosis,
essentially a fistula, in a minimally invasive way.
[0159] The method of the present invention for performing an
auto-anastomosis or a fistula would be to have one magnet in each
of the two hollow viscera and let them collapse. Because the
strength of attraction between the two magnets increases the closer
they are together, the magnets can apply enough force over time to
cause necrosis of the tissue between. If the timing is correct, the
tissue just outside the crushed tissue will essentially heal
together, creating a fistula. The magnet pair would then fall out
into the lumen and could be retrieved or passed.
[0160] Referring to FIG. 27, a method and system 800 for performing
a side-to-side anastomosis in two hollow viscera is described.
According the method of the present invention, a first magnetic
implant 802 is positioned in a first organ segment 806 at a region
or location where anastomosis and fistula is desired.
[0161] Delivery of the magnet to the desired location in the body
may be facilitated through open surgery or through a number of
minimally invasive approaches. For example, standard techniques
such as laparoscopy, thorascopy, fetoscopy and the like may be
employed, depending on the desired location and/or procedure. In
some procedures, delivery may be achieved without open surgery,
e.g. via gastrointestinal or urinary tract endoscopy.
[0162] FIG. 27 illustrates delivery to a location in organ segment
806 by use of a catheter 830. Catheter 830 may have a variety of
configurations currently available in the art for delivery of an
implant or other device through a lumen. For example, catheter 830
may have a catheter tube 834 housing remotely retractable grippers
832. The grippers 832 may hold the magnet 802 inside retractable
sheath 836 while the catheter 830 is delivered to the desired
location in the lumen. The sheath 836 may then be retracted to
allow the magnet 802 to be released at the location.
[0163] After placement of the first magnet, second magnetic implant
804 is delivered to a second organ section 808 in proximity to
first section 806. It is appreciated that organ segments 806/808
may be separate locations in the same organ, such as two sections
of bowel that are separated by an obstruction or atresia, or
separate but adjacent organs, such as between a ureter and bladder,
or arterial-venous fistula.
[0164] As shown in FIG. 27, implants 802 and 804 are generally
ring-shaped having a centrally located aperture 810. Alternatively,
implants 812 and 814, shown in FIG. 28, may be used that are disc
shaped. Implants 812 and 814 may be used in situations where an
obstruction can be temporarily tolerated until the fistula is
created (explained in more detail below). The implants are
generally comprised of a magnetically charged material. A coating
or hermetically sealed casing, such as titanium or epoxy, may
encapsulate the implants to ensure biocompatibility. The outside
diameter d.sub.o of the implant may vary according to the size of
the desired fistula. Accordingly, the inside diameter d.sub.i may
vary depending on the size of the temporary passage (described in
further detail below). It is also appreciated that the implant may
be configured to have one of a number of shapes depending on the
application, e.g. the outer and inner edges may be elliptical, or
other shape to accommodate the desired fistula.
[0165] Referring now to FIG. 29, the implants 802, 804 are placed
with opposite poles facing each other at the desired location for
the fistula. This creates an attractive force between the magnets
802 and 804, and the interior walls 816 and 818 between the
magnets. The attractive force also acts to concentrically align
magnets 802 and 804 along the same axis.
[0166] As illustrated in FIG. 30, the attractive force of the
magnets 802 and 804 draws the inner walls 816 and 818 together
until they contact each other. A compressive force is generated on
the tissue 820 of walls 816 and 818 between the magnets. This
compressive force gradually increases as the magnets get closure to
each other.
[0167] Referring now to FIG. 31 In situations where a temporary
passage for the contents of the viscera is desired or required
(e.g. an obstruction downstream from the implant location) a cutout
822 may be performed in the tissue 820 of walls 816 and 818. The
cutout may be circular to generally match the shape of hole 819 of
the magnets. As shown in FIG. 31, cutout 822 and holes 810 in the
magnets all flow F of the contents of the viscera to be immediately
restored to essentially bypass any downstream obstruction. Cutout
822 may be made non-invasively via a cutting tool (not shown)
disposed at the location via and catheter 830 (shown in FIG.
27).
[0168] Alternatively, disc-shaped magnets 812 and 814 may be used
where obstruction (or other condition) of the viscera is tolerable
for the period it takes to achieve auto-anastomosis. In this case,
no cutout is made in walls 820.
[0169] In either case, the compressive force placed on the tissue
820 trapped between the magnets causes necrosis of the tissue 820.
As shown in FIG. 32, the tissue eventually falls out over a period
of time (usually within days), and the walls 816 and 818 heal, or
fuse together to form a fistula 826 around the perimeter of the
magnets 802/804.
[0170] Finally in FIG. 33, the magnets 802/804 and necrosed tissue
between them (if any), fall out from the fistula 826 and may either
be retrieved, or simply pass out of the patient's system through
the newly anastamosed lumen.
[0171] The above described method and system for auto-anastomosis
may be performed on any hollow viscera, lumen, organ, etc. in the
body where anastomosis and/or fistula are conventionally performed.
For example the system 800 may be used for side-to-side anastomosis
in the vascular system, e.g. an arterial-venous fistula for
vascular access.
[0172] However, the methods and system 800 are ideally suited in
regions of the body that are more susceptible to necrosis under
high pressure, such as the gastrointestinal and urinary tracts.
[0173] Referring to FIG. 34 of the gastrointestinal tract, the
system 800 may be used to achieve anastomosis in the esophagus 840,
down to the stomach 842, small intestine 846 and colon 848. For
example, the anastomosis may be performed in bariatric procedures
such as gastric bypass.
[0174] In addition, system 800 may be used for palliative
procedures for bowel stenosis or obstruction, i.e. intestinal
atresia. Intestinal atresia may aoocur in a number of places in the
gastrointestinal tract, e.g. the duodenum 844, jejunum 850 and
ileum 852 of the small intestine 846, and colon 848. An
anastomosis/fistula may be readily performed in this regions given
the characteristics of the bowel, and the ease of placing segments
of these organs adjacent to each other to bypass an obstruction. In
certain types of jejunoileal atresia, where significant portions of
the small intestine are missing, the present invention may be
configured to stretch the separated intestinal lumens prior to
anastomosis, similar to the system disclosed in co-pending U.S.
application Ser. No. 11/222,517, incorporated herein by reference
in its entirety.
[0175] FIG. 35 illustrates a schematic diagram of a patient having
duodenal atresia. The duodenum 844 has a blockage 858 separating an
upper portion 854 from a lower portion 856 of the duodenum.
[0176] Referring now to FIG. 36, magnetic implants 802 and 804 are
delivered separately to each side of the blockage or atresia 858.
This may be achieved via separate catheters, similar to catheter
assembly 830, into the adjacent regions. For example, magnet 802
may be delivered via a catheter through the mouth and esophagus, or
via laparoscopy. Magnet 804 may also be delivered via laparoscopy,
or via endoscope. The magnets are positioned, and the segments 854
and/or 856 are maneuvered so that the magnets align adjacent to
each other across the tissue of each segment. The autoanstomosis
process, as depicted in FIGS. 30-33, occurs over a period of time
until a fistula is achieved and the magnets dislodge to be
retrieved or pass out of the system.
[0177] Referring now to FIG. 37, system 800 may also be implemented
to perform an anastomosis/fistula in the organs of the urinary
tract, including urethra 866, bladder 864, and ureters 860. For
example, implants 802 and 804 may be delivered to appropriate
locations to create a fistula between a ureter and the bladder, or
in the renal pelvis 870.
[0178] Referring now to FIGS. 38-39, system 880 may be implemented
to create an ostomy. As shown in FIG. 38, a magnetic implant 882
may be delivered to a desired location in the organ 886 to be
treated, e.g. the colon for a colostomy, small intestine for an
illeostomy, or ureter for a urostomy. The implant 882 may be
delivered via catheter 830 either by endoscope or laparoscope. An
external magnet 884 is then placed over the patient's skin 888
adjacent the internal magnet 882, with opposite polarities facing
each other so that an attractive force is generated between the
magnets.
[0179] The attractive force between magnets 882 and 884 generate a
compressive force on the tissue in between them, e.g. visceral wall
894, abdominal wall 890, and skin 888. This compressive force
causes the tissues to necrose, and eventually anastomose until the
magnets and tissue fall out, creating a fistula and stoma 892
through the visceral wall, abdominal wall and skin, as illustrated
in FIG. 39. A plastic pouch, e.g. colostomy bag, is then attached
to the skin 888 around stoma 892.
[0180] As shown in FIG. 40, the system may also include one or more
intermediate internal magnets 896 to better facilitate necrosis of
the abdominal wall 890. For example, the first implant 882 may be
inserted into the desired organ 886, and a second implant 896 may
be implanted in the abdominal wall between the skin 888 and
visceral wall 8894. The polarities of magnets 882, 894 and 884 are
aligned so that all three magnets attract toward each other. This
has the effect of shortening the distance between magnets, thereby
increasing the compressive force between them to facilitate
necrosis and auto-anastomosis. Two or more intermediate internal
magnets may also be used where necessary.
[0181] All magnetic members or implants heretofore disclosed may
have magnetic, ferromagnetic, or electromagnetic properties and may
include one or more materials, e.g. magnetic or non-magnetic
[0182] Therefore, it will be appreciated that the scope of the
present invention fully encompasses other embodiments which may
become obvious to those skilled in the art, and that the scope of
the present invention is accordingly to be limited by nothing other
than the appended claims, in which reference to an element in the
singular is not intended to mean "one and only one" unless
explicitly so stated, but rather "one or more." All structural,
chemical, and functional equivalents to the elements of the
above-described preferred embodiment that are known to those of
ordinary skill in the art are expressly incorporated herein by
reference and are intended to be encompassed by the present claims.
Moreover, it is not necessary for a device or method to address
each and every problem sought to be solved by the present
invention, for it to be encompassed by the present claims.
Furthermore, no element, component, or method step in the present
disclosure is intended to be dedicated to the public regardless of
whether the element, component, or method step is explicitly
recited in the claims. No claim element herein is to be construed
under the provisions of 35 U.S.C. 112, sixth paragraph, unless the
element is expressly recited using the phrase "means for."
* * * * *